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Commercial Eyes (ProductLife Group Company) is Australia's leading pharmaceutical and medical device commercialisation company. With a team of over 100 staff and 23 years of experience, over 900 pharmaceutical, medical device, diagnostic, and consumer healthcare companies rely on our expertise and insights.
As part of ProductLife Group, our local and regional expertise and insights, coupled with PLG's global presence and knowledge, enable us to deliver tailored, high-quality solutions to our clients locally and globally.
The Opportunity
The Consultant manages client projects, working closely with other team members to deliver a superior client experience, optimise project outcomes, and contribute to the culture and capabilities of the team.
This permanent, full-time position reports to the Manager and works within the Regulatory, Quality & Compliance team to deliver a range of regulatory, quality and compliance services within Australia, New Zealand and Japan and Asia Pacific (JAPAC) region.
The role acts as a Project Team Leader, participates in assigned projects and supports project teams as required.
The role contributes to the BU's business growth efforts by proactively identifying business development opportunities and working with existing and potential clients in the healthcare sector to anticipate and understand their business needs and identify areas or activities with which CE can assist.
Some key responsibilities include:
* Fostering relationships and collaborating with other business units to support cross-collaboration within the business, drive innovation, create efficiencies, and expand service offerings across the business.
* Providing high-quality work that contributes to client satisfaction and loyalty, leading to optimisation of repeat business and expansion of service provision across the Regulatory, Quality & Compliance service offering.
* Provide quality and compliance services to clients to support supply of registered or listed pharmaceuticals, biologicals and medical devices. This includes among other activities, reviewing and maintaining Quality Management Systems (QMS) and overseeing the release for distribution to ensure products meet regulatory standards.
* Lead and manage projects of varying sizes, coordinating both small and large project teams to support the needs of multiple clients, ensuring projects are completed on time and within scope.
* Provide expert advice on quality-related matters, offering both general guidance and strategic recommendations to clients to help them navigate complex regulatory requirements and improve their overall quality practices.
* Manage GMP clearance applications for submission to the TGA, including preparing and reviewing documentation, ensuring compliance with TGA standards, and coordinating with internal teams and clients to facilitate approval.
Desired qualifications and experience
* Have completed studies in pharmaceutical sciences or related scientific fields.
* Proven record of experience in quality assurance, preferably in both consulting and commercial environments.
* Good knowledge of legislation, regulations, guidelines and working procedures within the JAPAC region.
* Experience in auditing GMP (Good Manufacturing Practice) and/or GCP (Good Clinical Practice) processes in external audits, assessing compliance with manufacturing and clinical trial standards.
* Experience in the review, critical evaluation and presentation of technical data.
* Proven problem-solving and project management skills.
* Post-graduate qualifications in a relevant discipline are preferable.
Seniority level
Associate
Employment type
Full-time
Job function
Consulting and Other
Industries
Health and Human Services
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